Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum

NCT ID: NCT07283042

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-12-31

Brief Summary

This study evaluates the clinical implementation of intra-operative topographic classification system for PAS. In addition to a standard of care risk stratification prenatal ultrasound for patients with a risk of PAS, this study adds an additional intraoperative surgical staging protocol to validate the classification system, improve surgical approach, and significantly clinical outcomes of pregnant people with an a prior risk of PAS. The study will involve pregnant patients with PAS risk factor, include data collection spanning prenatal assessment, intraoperative classification, surgical technique implementation and postoperative analysis. The anticipated study duration is approximately 36-48 months.

Detailed Description

This study is a prospective cohort study designed to assess the validity, feasibility, and clinical utility of a topographic classification system for placenta accreta spectrum (PAS), with a primary focus on its application in the actual execution of surgery. This study is investigating a clinical decision flowchart used for intraoperative staging and classification of placenta accreta spectrum (PAS) or similar uterine surgical scenarios. It integrates topographic classification, surgical decision-making, and treatment strategy selection.

The classification system will directly guide and be integrated into real-time surgical planning and management-from cesarean hysterectomy to one-step conservative surgery-based on prenatal ultrasound staging and intraoperative findings.

• Standardizing prenatal ultrasound staging for PAS.
• Implementing a structured protocol for intraoperative classification and surgical execution according to ultrasound.
• Collecting and correlating surgical and pathological findings, including intraoperative photos, videos, and gross and histological analysis.
• Utilizing an objective method to quantify intraoperative blood loss.
• Comparing preoperative ultrasound findings with intraoperative and postoperative data to validate the classification system.
• Managing participant dropouts and protocol deviations to ensure data integrity and minimize bias.
• Applying appropriate statistical adjustments for multiple group comparisons to reduce the risk of type I error. Methods such as Bonferroni correction or false discovery rate adjustments will be utilized where applicable.
• Incorporating serial blood draws for plasma and whole blood analysis to identify potential biomarkers associated with PAS severity, surgical complexity, and clinical outcomes. This will be optional and stored in the biorepository.

Conditions

Placenta Accreta

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PAS

Patients with placental accreta undergoing planned surgical intervention for PAS

Total Hysterectomy

Intervention Type: PROCEDURE

Removal of entire uterus

Modified subtotal hysterectomy

Intervention Type: PROCEDURE

When partial tissue integrity is preserved

One-Step Conservative Surgery

Intervention Type: PROCEDURE

Considered when significant healthy myometrium is preserved

Interventions

Total Hysterectomy

Removal of entire uterus

Intervention Type: PROCEDURE

Modified subtotal hysterectomy

When partial tissue integrity is preserved

Intervention Type: PROCEDURE

One-Step Conservative Surgery

Considered when significant healthy myometrium is preserved

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Pregnant people suspected of having PAS based on ultrasound findings or clinical risk factors
• Patients undergoing planned surgical intervention for PAS, including a planned cesarean
• Individuals who provide informed consent to participate in the study
• Patients with at least one prenatal assessment before surgery
• Expected age range: 18-55
• Patient has agreed to conservative management approach as part of standard of care if feasible intraoperatively

Exclusion Criteria

• Patients who decline participation or withdraw consent
• Those with contraindications to the planned surgical procedure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Yalda Afshar, MD, PhD

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yalda Afshar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dana Levin-Lopez, MPH

Role: CONTACT

dlevinlopez@mednet.ucla.edu

310-794-8893

Facility Contacts

Dana Levin-Lopez, MPH

Role: primary

dlevinlopez@mednet.ucla.edu

310-794-8893

Other Identifiers

24-6300

Identifier Type: -

Identifier Source: org_study_id